BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EXETER OPERATING LOUPE

    K Number: K863983 · Decision Nov 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    EXETER OPERATING LOUPE
    K Number
    K863983
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Exeter Instruments, Inc.
    Date Received
    October 14, 1986
    Decision Date
    November 10, 1986
    Product Code
    HJH
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJH Loupe, Binocular, Low Power

    Similar 510(k) Clearances

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    MALIS SURGICAL LOUPES

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    BINOCULAR LOUPE

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    Other Clearances by Exeter Instruments, Inc.

    K Number Device Name
    K810817 EXETER OPERATING LOUPE